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The purpose of this study was to determine whether adding Lidocaine to Corticosteroid injections reduce pain intensity in hand surgery.
There is a lack of evidence about the use of lidocaine injection as an addition to steroids against pain during injections. Adding lidocaine adds to the volume of the injection, which might increase pain. It's possible that injecting cortisone without any lidocaine would be more comfortable than with lidocaine.
The aim of this randomized controlled trial is to assess the difference in pain intensity (during the injection and 4 hours later) between patients receiving a corticosteroid injection with or without lidocaine in patients with a hand condition. Secondarily, the aim of this study is to assess factors independently associated with pain intensity, satisfaction with the visit, and perceived empathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corticosteroid with Lidocaine | Experimental | The group with the lidocaine will get a combined injection with a steroid and lidocaine. The dosages depend on the disease. The steroid dosage will be the same as for the group without lidocaine.
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| Corticosteroid without Lidocaine | Active Comparator | The group without the lidocaine will get an injection with only steroids. The steroid dosage depends on the disease and will be the same as for the group with the lidocaine:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | The group with the lidocaine will get a combined injection with a corticosteroid and lidocaine. The dosages depend on the disease. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity during injection | 11-point ordinal scale, with 0 for no pain at all and 10 for worst pain ever | During Injection |
| Pain Catastrophizing Scale (PCS 4) | A 4 item questionnaire with a range of 0(no pain catastrophizing thoughts) to 16(maximum pain catastrophizing thoughts) | through study completion, an average of 6 weeks |
| Patient Health Questionnaire (PHQ 2) | a 2 item questionnaire measuring depression symptoms with a range of 0(no depression symptoms 0 to 6(maximum depression symptoms) | through study completion, an average of 6 weeks |
| Pain Self-efficacy Questionnaire (PSEQ 2) | A measure of effective coping strategies with a range of 0(no coping strategy) to 12(maximum coping strategies) | through study completion, an average of 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity 4 hours after injection | 11-point ordinal scale, with 0 for no pain at all and 10 for worst pain ever | 4 hours after injection |
| Pain intensity 5 minutes after injection | 11-point ordinal scale, with 0 for no pain at all and 10 for worst pain ever |
| Measure | Description | Time Frame |
|---|---|---|
| Jefferson scale of patient perception of physician empathy | a 5 item questionnaire of patient's perceived empathy with a range of 5(minimum perceived empathy) to 35( maximum perceived empathy) | through study completion, an average of 6 weeks |
Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Ring, MD, PhD | UT Health Austin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Austin (UTHA) | Austin | Texas | 78701 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 6, 2026 | |
| Reset | Jun 30, 2026 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 18, 2019 | Jul 18, 2019 | Prot_SAP_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 6, 2026 | Jun 30, 2026 |
| ID | Term |
|---|---|
| D052582 | Trigger Finger Disorder |
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D053682 | Tendon Entrapment |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Patients will be randomized in two groups for the corticosteroid injection, one group with lidocaine and one group without lidocaine.
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To make this a double-blind study, the medical assistant will put a piece of tape around the syringe to cover up the volume.
| Corticoids | Drug | The group without the lidocaine will get an injection with only corticosteroids. The corticosteroid dosage depends on the disease and will be the same as for the group with the lidocaine: |
|
| 5 minutes after injection |
| D020423 |
| Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
| Aniline Compounds |
| D000588 | Amines |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |